Changes in demographics, treatment and outcomes in a consecutive cohort who underwent transcatheter aortic valve implantation between 2005 and 2020.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) has matured to the treatment of choice for most patients with aortic stenosis (AS). We sought to identify trends in patient and procedural characteristics, and clinical outcomes in all patients who underwent TAVI between 2005 and 2020. METHODS: A single-centre analysis was performed on 1500 consecutive patients who underwent TAVI, divided into three tertiles (T) of 500 patients treated between November 2005 and December 2014 (T1), January 2015 and May 2018 (T2) and June 2018 and April 2020 (T3). RESULTS: Over time, mean age and gender did not change (T1 to T3: 80, 80 and 79 years and 53%, 55% and 52% men, respectively), while the Society of Thoracic Surgeons risk score declined (T1: 4.5% to T3: 2.7%, p < 0.001). Use of general anaesthesia also declined over time (100%, 24% and 1% from T1 to T3) and transfemoral TAVI remained the default approach (87%, 94% and 92%). Median procedure time and contrast volume decreased significantly (186, 114 and 56 min and 120, 100 and 80 ml, respectively). Thirty-day mortality (7%, 4% and 2%), stroke (7%, 3% and 3%), need for a pacemaker (19%, 22% and 8%) and delirium (17%, 12% and 8%) improved significantly, while major bleeding/vascular complications did not change (both approximately 9%, 6% and 6%). One-year survival was 80%, 88% and 92%, respectively. CONCLUSION: Over our 15 years' experience, patient age remained unchanged but the patient risk profile became more favourable. Simplification of the TAVI procedure occurred in parallel with major improvement in outcomes and survival. Bleeding/vascular complications and the need for pacemaker implantation remain the Achilles' heel of TAVI.

Clinical consequences of consecutive self-expanding transcatheter heart valve iterations.

OBJECTIVE: To compare early clinical outcomes after transcatheter aortic valve implantation (TAVI) with three consecutive generations of self-expanding valves (SEVs). METHODS: Clinical endpoints of consecutive patients who underwent TAVI with CoreValve, Evolut R or Evolut PRO were included in a prospective database. RESULTS: TAVI was performed with CoreValve (n = 116), Evolut R (n = 160) or Evolut PRO (n = 92). Evolut R and Evolut PRO showed a tendency towards lower permanent pacemaker implantation (PPI) rates compared to CoreValve (CoreValve 27% vs Evolut R 16% vs Evolut PRO 18%, p = 0.091). By multivariable regression analysis CoreValve had a significantly higher risk for PPI (odds ratio (OR) 2.79, 95% confidence interval (CI) 1.31-5.94, p = 0.008) compared to Evolut R, while Evolut R and PRO were similar. Severe paravalvular leakage (PVL) occurred only with CoreValve, but no significant difference was observed in moderate PVL (10% vs 8% vs 6%, p = 0.49). CoreValve had a tendency towards a higher risk for more-than-mild PVL as compared with the Evolut platform (R + PRO) (OR 2.46, 95% CI 0.98-6.16, p = 0.055). No significant differences in all-cause mortality (7% vs 4% vs 1%, p = 0.10), stroke (6% vs 3% vs 2%, p = 0.21) or major vascular complications (10% vs 12% vs 4%, p = 0.14) were observed. CONCLUSIONS: TAVI with self-expanding valves was safe, and device iterations may result in a lower need for PPI. More-than-mild PVL seemed to occur less often with repositionable technology.

Transcatheter mitral valve repair in proportionate and disproportionate functional mitral regurgitation-insights from a small cohort study.

BACKGROUND: Functional mitral regurgitation (FMR) can be subclassified based on its proportionality relative to left ventricular function and end-diastolic volume. FMR proportionality could help identify responders to transcatheter edge-to-edge mitral valve repair (MitraClip) in terms of residual FMR and/or clinical improvement. METHODS: This single-centre retrospective cohort study evaluated the feasibility of determining FMR proportionality in symptomatic heart failure patients with reduced left ventricular function who were treated with MitraClip for ≥ moderate-to-severe FMR. Baseline proportionate (pFMR) and disproportionate FMR (dFMR) were distinguished. Patient characteristics and MitraClip procedural outcomes were described. RESULTS: From an overall cohort of 81 eligible FMR patients, 23/81 (28%) had to be excluded due to missing transthoracic echocardiogram parameters, 22/81 were excluded based on FMR severity. The remaining cohort, of 36/81 patients (44%), could be classified into dFMR (n = 26) or pFMR (n = 10). Conduction disorders were numerically increased in dFMR. All cases requiring > 2 clips were in the dFMR group and absence of FMR reduction occurred more frequently with dFMR. POINT OF VIEW/CONCLUSION: Important limitations in terms of imaging acquisition affect the translation of the FMR proportionality concept to a real-world data set. We did observe different demographic and FMR response patterns in patients with proportionate and disproportionate FMR that warrant further investigation.

Treatment decision for transcatheter aortic valve implantation: the role of the heart team : Position statement paper of the Dutch Working Group of Transcatheter Heart Interventions.

The current paper presents a position statement of the Dutch Working Group of Transcatheter Heart Valve Interventions that describes which patients with aortic stenosis should be considered for transcatheter aortic valve implantation and how this treatment proposal/decision should be made. Given the complexity of the disease and the assessment of its severity, in particular in combination with the continuous emergence of new clinical insights and evidence from physiological and randomised clinical studies plus the introduction of novel innovative treatment modalities, the gatekeeper of the treatment proposal/decision and, thus, of qualification for cost reimbursement is the heart team, which consists of dedicated professionals working in specialised centres.

An update on the use of anticoagulant therapy in ST-segment elevation myocardial infarction.

INTRODUCTION: Together with antiplatelet therapy, anticoagulants are vital to improve outcomes in patients presenting with ST-segment elevation myocardial infarction. Challenges lie in finding the optimal balance between the risk of bleeding and preventing thrombotic complications such as reinfarction or stent thrombosis. During the last decade, bivalirudin was introduced as a valid alternative to heparin for patients undergoing primary percutaneous coronary intervention. Several trials have been conducted to identify the agent with the best antithrombotic results at the lowest bleeding complication rate. In a rapidly evolving field with changes in vascular access, available P2Y12 inhibitors, and indications for glycoprotein IIb/IIIa inhibitor administration, conflicting evidence became available. AREAS COVERED: This paper mainly focuses on the evidence above and gives brief discussion to the recent literature on anticoagulation in fibrinolytic therapy and advances in antiplatelet therapy. EXPERT OPINION: To date, no robust evidence is available challenging unfractionated heparin as the primary choice for anticoagulation in patients presenting with ST-segment elevation myocardial infarction. Further research should include efforts to refine anticoagulation strategies on an individual patient level. For patients undergoing primary percutaneous coronary intervention, bivalirudin could be used as an alternative to unfractionated heparin, while enoxaparin or fondaparinux is an alternative agent for patients treated with fibrinolytic therapy.

Are BVS suitable for ACS patients? Support from a large single center real live registry.

OBJECTIVES: To investigate one-year outcomes after implantation of a bioresorbable vascular scaffold (BVS) in patients presenting with acute coronary syndrome (ACS) compared to stable angina patients. BACKGROUND: Robust data on the outcome of BVS in the setting of ACS is still scarce. METHODS: Two investigator initiated, single-center, single-arm BVS registries have been pooled for the purpose of this study, namely the BVS Expand and BVS STEMI registries. RESULTS: From September 2012-October 2014, 351 patients with a total of 428 lesions were enrolled. 255 (72.6%) were ACS patients and 99 (27.4%) presented with stable angina/silent ischemia. Mean number of scaffold/patient was 1.55±0.91 in ACS group versus 1.91±1.11 in non-ACS group (P=0.11). Pre- and post-dilatation were performed less frequent in ACS patients, 75.7% and 41.3% versus 89.0% and 62.0% respectively (P=0.05 and P=0.001). Interestingly, post-procedural acute lumen gain and percentage diameter stenosis were superior in ACS patients, 1.62±0.65mm (versus 1.22±0.49mm, P<0.001) and 15.51±8.47% (versus 18.46±9.54%, P=0.04). Major adverse cardiac events (MACE) rate at 12months was 5.5% in the ACS group (versus 5.3% in stable group, P=0.90). One-year definite scaffold thrombosis rate was comparable: 2.0% for ACS population versus 2.1% for stable population (P=0.94), however, early scaffold thromboses occurred only in ACS patients. CONCLUSIONS: One-year clinical outcomes in ACS patients treated with BVS were similar to non-ACS patients. Acute angiographic outcomes were better in ACS than in non-ACS, yet the early thrombotic events require attention and further research.

Predictors of paravalvular aortic regurgitation following self-expanding Medtronic CoreValve implantation: the role of annulus size, degree of calcification, and balloon size during pre-implantation valvuloplasty and implant depth.

OBJECTIVES: We sought to investigate the role of balloon size during pre-implantation valvuloplasty in predicting AR and optimal Medtronic CoreValve (MCS) implantation depth. BACKGROUND: Paravalvular aortic regurgitation (AR) is common following MCS implantation. A number of anatomical and procedural variables have been proposed as determinants of AR including degree of valve calcification, valve undersizing and implantation depth. METHODS: We conducted a multicenter retrospective analysis of 282 patients who had undergone MCS implantation with prior cardiac CT annular sizing between 2007 and 2011. Native valve minimum (Dmin), maximum (Dmax) and arithmetic mean (Dmean) annulus diameters as well as agatston calcium score were recorded. Nominal and achieved balloon size was also recorded. AR was assessed using contrast angiography at the end of each procedure. Implant depth was measured as the mean distance from the nadir of the non- and left coronary sinuses to the distal valve frame angiographically. RESULTS: 29 mm and 26 mm MCS were implanted in 60% and 39% of patients respectively. The majority of patients (N=165) developed AR <2 following MCS implantation. AR ≥3 was observed in 16% of the study population. High agatston calcium score and Dmean were found to be independent predictors of AR ≥3 in multivariate analysis (P<0.0001). Nominal balloon diameter and the number of balloon inflations did not influence AR. However a small achieved balloon diameter-to-Dmean ratio (≤0.85) showed modest correlation with AR ≥3 (P=0.04). This observation was made irrespective of the degree of valve calcification. A small MCS size-to-Dmean ratio is also associated with AR ≥3 (P=0.001). A mean implantation depth of ≥8+2mm was also associated with AR ≥3. Implantation depth of ≥12 mm was associated with small MCS diameter-to-Dmean ratio and increased 30-day mortality. CONCLUSION: CT measured aortic annulus diameter and agatston calcium score remain important predictors of significant AR. Other procedural predictors include valve undersizing and low implantation depth. A small achieved balloon diameter-to-Dmean ratio might also predict AR ≥3. Our findings confirm that a small achieved balloon size during pre-implantation valvuloplasty predicts moderate-severe AR in addition to previously documented factors.

Transcatheter device closure of atrial septal defects in patients aged 40 years and older.

OBJECTIVE: To evaluate the safety and effect of transcatheter device closure in ostium secundum atrial septal defects (ASD II) in patients aged 40 years and older. METHODS: Retrospective single-centre study concerning 47 consecutive ASD transcatheter occlusion procedures performed between January 1999 and December 2008. Electrocardiography, echocardiography and clinical assessments of the patients were conducted pre- and post-intervention and at follow-up. RESULTS: Of the 130 patients who were referred for interventional ASD closure, 47 were 40 years and older and all of them actually had the device inserted. There were no major complications during the intervention. Mean follow-up time was 15±15 months. During follow-up, three patients needed surgical reintervention because of device embolisation (n=2) or dislocation (n=1). Of the patients with severe right ventricular (RV) dilatation, more than half (58%) had no or mild dilatation at last follow-up. Reduction of RV dilatation was not related to age. Pulmonary hypertension was present in 63% before the procedure and was reduced to 38% at follow-up. NYHA class improved in all age groups, also in patients over 60 years of age. In two of the three patients who died during follow-up, no cause of death could be established, but both had responded well to treatment regarding the echocardiographic and clinical findings. CONCLUSION: Transcatheter device closure of ASD is a successful and effective treatment, also for patients aged 40 years and older. Patients showed regression of right ventricular enlargement and an improvement in functional class. (Neth Heart J 2010;18:537-42.).

Endovascular stenting for aortic (re)coarctation in adults.

Objectives. Stenting for native and recurrent coarctation (COA) in adults has become an important therapeutic strategy. In this prospective observational study we evaluated the intermediate-term outcome of stent implantation for either native or recurrent (re)COA in adults.Methods. All adults who underwent stent implantation in our institution between January 2003 and December 2008 were included. Diagnosis of (re)COA was based upon a combination of clinical signs, noninvasive imaging or invasive gradient measurements. NuMED stents were implanted under general anaesthesia.Results. Twenty-four patients (50% male) underwent stent implantation for native (n=6) or reCOA (n=18) at a median age of 36 (18 to 60) years. There was significant improvement in pre- versus post-stent invasive systolic gradient (19 vs. 0 mmHg, p<0.001) and COA diameter (10 vs. 16 mm, p<0.001). Acute complications (12.5%) included death due to aortic rupture despite immediate successful coverage with a covered stent (n=1) and groin haematoma (n=2). During a median follow-up period of 33 (8 to 77) months (n=22), late complications occurred in three patients (13.6%): stent migration to the ascending aorta (n=1), pseudoaneurysm at the site of the initial stent (n=1), and occluded external iliac artery (n=1). Stent implantation did not reduce the need for antihypertensive medication or blood pressure at last follow-up. Conclusion. COA stenting results in a significant gradient decrease and increase in vessel diameter. However, serious complications do occur and hypertension remains in the majority of patients. (Neth Heart J 2010;18:430-6.).

Patent ductus arteriosus in adults: Case report and review illustrating the spectrum of the disease.

Patent ductus arteriosus (PDA) is a congenital heart defect in which the ductus arteriosus, a vascular structure between the pulmonary artery and the aorta that normally closes shortly after birth, remains open. We present two cases of adults with PDA. A 28-year-old lady had a small PDA without any symptoms or left heart overload. The PDA was closed for endocarditis prevention using a coil. In a 37-year-old lady with palpitations, collapse, dyspnoea and left heart overload caused by a large PDA, percutaneous closure of the PDA was performed with an Amplatzer device. Transcatheter closure has been established to be the method of choice for treating a PDA in adults. (Neth Heart J 2008;16:255-9.).

Coronary artery remodelling is related to plaque composition.

OBJECTIVE: To assess the potential relation between plaque composition and vascular remodelling by using spectral analysis of intravascular ultrasound (IVUS) radiofrequency data. METHODS AND RESULTS: 41 coronary vessels with non-significant (< 50% diameter stenosis by angiography), < or = 20 mm, non-ostial lesions located in non-culprit vessels underwent IVUS interrogation. IVUS radiofrequency data obtained with a 30 MHz catheter, were analysed with IVUS virtual histology software. A remodelling index (RI) was calculated and divided into three groups. Lesions with RI > or = 1.05 were considered to have positive remodelling and lesions with RI < or = 0.95 were considered to have negative remodelling. Lesions with RI > or = 1.05 had a significantly larger lipid core than lesions with RI 0.96-1.04 and RI < or = 0.95 (22.1 (6.3) v 15.1 (7.6) v 6.6 (6.9), p < 0.0001). A positive correlation between lipid core and RI (r = 0.83, p < 0.0001) and an inverse correlation between fibrous tissue and RI (r = -0.45, p = 0.003) were also significant. All of the positively remodelled lesions were thin cap fibroatheroma or fibroatheromatous lesions, whereas negatively remodelled lesions had a more stable phenotype, with 64% having pathological intimal thickening, 29% being fibrocalcific lesions, and only 7% fibroatheromatous lesions (p < 0.0001). CONCLUSIONS: In this study, in vivo plaque composition and morphology assessed by spectral analysis of IVUS radiofrequency data were related to coronary artery remodelling.

One year clinical follow up of paclitaxel eluting stents for acute myocardial infarction compared with sirolimus eluting stents.

OBJECTIVE: To compare clinical outcome of paclitaxel eluting stents (PES) versus sirolimus eluting stents (SES) for the treatment of acute ST elevation myocardial infarction. DESIGN AND PATIENTS: The first 136 consecutive patients treated exclusively with PES in the setting of primary percutaneous coronary intervention for acute myocardial infarction in this single centre registry were prospectively clinically assessed at 30 days and one year. They were compared with 186 consecutive patients treated exclusively with SES in the preceding period. SETTING: Academic tertiary referral centre. RESULTS: At 30 days, the rate of all cause mortality and reinfarction was similar between groups (6.5% v 6.6% for SES and PES, respectively, p = 1.0). A significant difference in target vessel revascularisation (TVR) was seen in favour of SES (1.1% v 5.1% for PES, p = 0.04). This was driven by stent thrombosis (n = 4), especially in the bifurcation stenting (n = 2). At one year, no significant differences were seen between groups, with no late thrombosis and 1.5% in-stent restenosis (needing TVR) in PES versus no reinterventions in SES (p = 0.2). One year survival free of major adverse cardiac events (MACE) was 90.2% for SES and 85% for PES (p = 0.16). CONCLUSIONS: No significant differences were seen in MACE-free survival at one year between SES and PES for the treatment of acute myocardial infarction with very low rates of reintervention for restenosis. Bifurcation stenting in acute myocardial infarction should, if possible, be avoided because of the increased risk of stent thrombosis.

Off-pump coronary artery bypass surgery compared with stent implantation and on-pump bypass surgery: clinical outcome and cost-effectiveness at one year.

BACKGROUND: Coronary revascularisation by means of surgery or percutaneous intervention plays an important role in the management of patients with ischaemic heart disease. Coronary bypass surgery without cardiopulmonary bypass (off-pump surgery) has been reintroduced into clinical practice to avoid complications related to the use of cardiopulmonary bypass. It is unknown whether off-pump surgery can match the outcomes of bypass surgery with cardiopulmonary bypass (on-pump surgery) or intracoronary stent implantation. METHODS: The Octopus study comprised two multicentre randomised trials. In the Octopump trial, on-pump surgery was compared with off-pump surgery (139 vs. 142 patients). In the Octostent trial stent implantation was compared with off-pump surgery (138 vs. 142 patients). The primary cardiac endpoint was survival free from the following cardiovascular events: stroke, myocardial infarction and repeated coronary revascularisation. Secondary endpoints included quality of life and cost-effectiveness. The uncertainty surrounding the cost-effectiveness analysis was addressed by bootstrapping. RESULTS: Octopump trial: at one year, event-free survival in the on-pump group was 90.6% and in the off-pump group 88.0% (difference 2.6%, 95% CI-4.6 to 9.8). Quality-adjusted years of life were 0.83 and 0.82 (p=0.81), respectively. On-pump surgery was associated with €2089 (14.1%) additional direct medical costs per patient (p<0.01). Off-pump was more cost-effective than on-pump surgery in 95% of bootstrap estimates. Octostent trial: at one year, event-free survival in the stent group was 85.5% and in the off-pump surgery group 91.5% (difference -6.0%, 95% CI -13.5 to 1.4). Quality-adjusted years of life were 0.82 and 0.79 (p=0.09), respectively. Stent implantation reduced direct medical costs by €2813 (26.0%) per patient (p=0.01). Stent implantation was more cost-effective in 95% of bootstrap estimates. CONCLUSION: In selected patients eligible for bypass surgery, there was no difference in cardiac outcome between on-pump and off-pump surgery. Off-pump surgery, however, was more cost-effective than on-pump surgery and may be preferred from an economic perspective. In selected patients eligible for percutaneous coronary intervention, stent implantation was more cost-effective than off-pump surgery while maintaining comparable cardiac outcome. Therefore, stent implantation rather than off-pump surgery can be recommended as a first-choice revascularisation strategy.

Association between early and three month cognitive outcome after off-pump and on-pump coronary bypass surgery.

OBJECTIVE: To describe the association between cognitive outcome in the first postoperative week and that at three months after both off-pump and on-pump coronary bypass surgery, and to make a direct comparison of early cognitive outcome after off-pump versus on-pump surgery. DESIGN: Randomised trial with an additional prediction study within the two randomised groups. SETTING: Three centres for heart surgery in the Netherlands. PATIENTS: 281 patients, mean age 61 years. INTERVENTIONS: Participants were randomly assigned to off-pump or on-pump coronary bypass surgery. MAIN OUTCOME MEASURES: Cognitive outcome, assessed by psychologists who administered neuropsychological tests one day before and four days and three months after surgery. A logistic regression model was used to study the predictive association between early cognitive outcome, together with eight clinical variables, and cognitive outcome after three months. RESULTS: Cognitive outcome in the first week after surgery was determined for 219 patients and was a predictor of cognitive decline after three months. This association was stronger in on-pump patients (odds ratio (OR) 5.24, p < 0.01) than in off-pump patients (OR 1.80, p = 0.23). Early decline was present in 54 patients (49%) after off-pump surgery and 61 patients (57%) after on-pump surgery (OR 0.73, p = 0.25). CONCLUSIONS: In patients undergoing first time coronary bypass surgery, early cognitive decline predicts cognitive outcome after three months. Early cognitive decline is not significantly influenced by the use of cardiopulmonary bypass.

Homocysteine and the stage of atherosclerotic disease: a study in patients suffering from clinically silent and clinically manifest atherosclerotic disease.

BACKGROUND: Elevated serum levels of homocysteine are considered a risk factor for cardiovascular disease. It has been suggested that homocysteine is a late stage predictor of adverse cardiovascular events, which might explain reported controversies in literature. The objective of the present study was to study the relationship between homocysteine levels and the stage of atherosclerotic disease. METHODS: In a cross-sectional study we compared the prevalence of hyperhomocysteinemia in high risk patients without silent or clinically overt atherosclerosis (group I, n = 196) with two patient groups: patients with clinically manifest atherosclerosis in the past or asymptomatic atherosclerosis (group II, n = 364) and patients who currently suffer from a clinically relevant manifestation of ischemic cardiovascular disease (group III, n = 967). In addition, we related homocysteine levels with a cumulative index of atherosclerotic disease (SMART-score). RESULTS: Homocysteine levels (micromol L(-1)) for the different groups were 13.5 +/- 8.9 (group I), 13.7 +/- 8.2 (group II) and 14.7 +/- 7.7 (group III). After adjustment for age, body mass index, creatinine levels and current use of vitamins, no significant differences in the prevalence of hyperhomocysteinemia were observed, compared with the reference category. Linear regression analysis revealed a significant relationship between Smart score and homocysteine levels that remained after adjustment for potential confounders (Beta = 0.36 (0.14-0.59), P = 0.001). CONCLUSION: If homocysteine levels are associated with the presence and indicators of atherosclerotic plaque burden, then this relationship is apparently not affected by the stage of atherosclerotic disease.